LEADER DIAPER RASH- zinc oxide ointment 
CARDINAL HEALTH

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient                                                                       Purpose

Zinc oxide, 40% .....................................................................Skin protectant

Uses

Warnings

For external use only

Do not use

over deep or puncture wounds, infections or lacerations

When using this product avoid contact with the eyes

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

butylhydroxyanisole, lavendar oil, liquid paraffin, methylparaben, polysorbate 60, purified lanolin, sorbitan monostearate, squalane, talc, tocopherol acetate, water, white petrolatum

Distributed By Cardinal Health

Dublin, Ohio 43017

www.myleader.com

Made in Korea

image description

LEADER DIAPER RASH 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-637
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.40 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PARAFFIN (UNII: I9O0E3H2ZE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
LANOLIN (UNII: 7EV65EAW6H)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
SQUALANE (UNII: GW89575KF9)  
TALC (UNII: 7SEV7J4R1U)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-637-261 in 1 CARTON10/11/2016
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/20/2012
Labeler - CARDINAL HEALTH (097537435)

Revised: 10/2016
Document Id: 1354cdf4-4ca9-4c66-9051-1ca5acc66a7b
Set id: d4acd714-5a67-41c0-9c87-bd7f248733b6
Version: 2
Effective Time: 20161011
 
CARDINAL HEALTH